Reasoning: Action 10

FDA will explain via the FDA Basics for Industry web-based resource how a sponsor is informed about whether the review of its product application is on track to meet the target date for FDA action on the application. FDA is also willing to hold further discussions with industry about application tracking systems, and explore the feasibility of implementing such a system at FDA.

Reasoning:

The agency has published milestones of key events during the course of the review process. Many product applications submitted to the agency are associated with performance goals for review. In most cases, the agency succeeds in meeting those target timeframes.

FDA communicates with sponsors as questions arise during the review process. FDA’s requests for additional information provide a gauge of the agency’s progress reviewing an application. Providing information to sponsors about this process may address some of sponsors’ concerns articulated in comments to the Transparency Task Force.

FDA representatives participated in an initial discussion with representatives from Health Canada about the application tracking system used by that agency. FDA’s initial sense was that the system did not provide a significant increase in the amount or quality of information available to a sponsor or applicant regarding their submission. The majority of the information available via the Health Canada tracking system is transmitted by FDA’s review offices to the sponsor via email, telephone, or facsimile. Further, the security needs inherent in developing a tracking system for all applications that can be accessed by individual sponsors and yet keeps product application information confidential would require significant resources.

But Health Canada’s experience implementing an application tracking system suggests that such a system could substantially reduce the need for communications between sponsors and FDA review staff concerning the status of applications. FDA is open to further discussions to gain a better understanding of the benefits to industry of an application tracking system and the feasibility of implementing such a system at FDA.